ROBOTIC PYELOLITHIOTOMY VERSUS PERCUTANEOUS NEPHROLITHOTOMY (PCNL).

NCT03046888 | Completed DMC

• 1 other identifier: SJ-598
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Prospectively randomized study in patients with renal pelvic stones who are candidate to standard PCNL procedure. One to one, controlled clinical trial. Patients will be randomly allocated into two groups, 20 patients in each group. Group A will be scheduled to receive routine standard PCNL. Group B will be scheduled to receive Robot assisted pyelolethotomy.

Conditions

Renal Stone

Outcome Measures

Primary Outcomes (1)

• Postoperative hospital stay

  the length of hospital stay efter each procedure

  30 days

Secondary Outcomes (1)

• Stones free rate

  6 months

Study Arms (2)

PCNL

EXPERIMENTAL

Percutant nephrolithotomy is a standard procedure for stones treatment over 2 cm.The puncture will be performed with an 18-G nephrostomy needle. The access thus gained guaranteed the transpapillary route of the percutaneous tract, a basic condition for the prevention of bleeding. Subsequently, following withdrawal of the puncture needle and urine drainage, a flexible guidewire will be inserted and advanced to the upper calyx or ureter.

Procedure: Robot assisted pyelolithotomy

Robot assisted pyelolithotomy

EXPERIMENTAL

Robot assisted pyelolithotomy, is a new technique to remove stones of more than 2 cm. A 12-mm camera port is placed at the level of the umbilicus and lateral. Two 8-mm robotic trocars are placed under direct vision and a 12-mm assistant port is placed in the midline a 5-8 cm above the umbilicus. After reflecting the colon medially, the renal pelvis will be dissected and identified, a flexible cystoscope will be inserted via an assisted trocar and introduced into the renal pelvis through a minor incision. The kidney stones will then be extracted with a basket and either removed via the port or placed in a specimen retrieval bag.

Procedure: Robot assisted pyelolithotomy

Interventions

Robot assisted pyelolithotomy PROCEDURE

A 12-mm camera port is placed at the level of the umbilicus and lateral; this port is moved farther laterally in morbidly obese patients to allow for the instruments to reach the target organs. Two 8-mm robotic trocars are placed under direct vision and a 12-mm assistant port is placed in the midline a 5-8 cm above the umbilicus. For right-sided stones, an additional 5-mm port is placed in the midline just below the xiphoid process for liver retraction. Placement of the trocars can be changed according to surgeon preference. After reflecting the colon medially, the renal pelvis will be dissected and identified, a flexible cystoscope will be inserted via an assisted trocar and introduced into the renal pelvis through a minor incision. The kidney stones will then be extracted with a basket and either removed via the port or placed in a specimen retrieval bag.

PCNL; Robot assisted pyelolithotomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age above 18 years.
• Renal stones ≥2 cm.
• Patients are candidate to PCNL.
• Patient with ECOG performance score of 2 and less.
• Able to give informed consent
• Able to discharges home at the same day.

You may not qualify if:

• Renal stones \< 2cm and can managed by another technique.
• Known with psychological disease.

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

Zealand University Hospital

Roskilde, 4000, Denmark

Location

MeSH Terms

Conditions

Nephrolithiasis

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Urologist

Model Details: Prospectively randomized study in patients with renal pelvic stones who are candidate to standard PCNL procedure. One to one, controlled clinical trial. Patients will be randomly allocated into two groups, 20 patients in each group. Group A will be scheduled to receive routine standard PCNL. Group B will be scheduled to receive RP.

Study Record Dates

• First Submitted: February 5, 2017
• First Posted: February 8, 2017
• Study Start: October 1, 2017
• Primary Completion: February 13, 2020
• Study Completion: February 13, 2020
• Last Updated: February 17, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)